Overview

This trial is active, not recruiting.

Condition peripheral artery disease
Treatment zilver® ptx® drug-eluting peripheral stent
Sponsor Cook
Start date June 2014
End date December 2015
Trial size 178 participants
Trial identifier NCT02171962, 13-008

Summary

The objective of this study is to evaluate the Zilver® PTX® Drug-Eluting Peripheral Stent for treatment of lesions of the above-the-knee femoropopliteal artery in a Chinese patient population.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
zilver® ptx® drug-eluting peripheral stent
Zilver® PTX® Drug-Eluting Peripheral Stent for treatment of lesions of the above-the-knee femoropopliteal artery

Primary Outcomes

Measure
Primary Patency as Assessed by Duplex Ultrasonography
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Symptoms of peripheral arterial disease corresponding to Rutherford Classification 2-4 - Stenotic (>50% diameter stenosis) or occluded lesion of the above-the knee femoropopliteal artery - Reference vessel diameter of 4-9 mm - Lesion length up to 140 mm Exclusion Criteria: - Unsuccessful arterial interventional treatment of the legs within 30 days prior to the study procedure - Previous stent in the study vessel - Bypass graft with an anastomosis in the study vessel - Significant stenosis or occlusion of inflow tract not successfully treated prior to treating the study lesion - No patent vessel of runoff

Additional Information

Official title Evaluation of the Zilver® PTX® Drug-Eluting Peripheral Stent for Treatment of Lesions of the Above-the-Knee Femoropopliteal Artery
Principal investigator Changwei Liu, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Cook.